TY - JOUR
T1 - Surgical Safety of Cytoreductive Nephrectomy Following Sunitinib
T2 - Results from the Multicentre, Randomised Controlled Trial of Immediate Versus Deferred Nephrectomy (SURTIME)
AU - De Bruijn, Roderick Emile
AU - Mulders, Peter
AU - Jewett, Michael A.
AU - Wagstaff, John
AU - Van Thienen, Johan V.
AU - Blank, Christian U.
AU - Van Velthoven, Roland
AU - Wood, Lori
AU - van Melick, Harm E.
AU - Aarts, Maureen J.
AU - Lattouf, Jean B.
AU - Powles, Thomas
AU - De Jong, Igle J.
AU - Rottey, Sylvie
AU - Tombal, Betrand
AU - Marreaud, Sandrine
AU - Collette, Sandra
AU - Collette, Laurence
AU - Haanen, John B.
AU - Bex, Axel
N1 - Funding Information:
Financial disclosures: Axel Bex certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Dr. Bex reported receiving grants from Pfizer during the conduct of the study; receiving personal fees from Pfizer, Eisai Co., Ipsen, EUSA, and Bristol-Myers Squibb; and serving as a member of the steering committee of the IMMotion 010 adjuvant trial in renal cell carcinoma from Roche, outside the submitted work. Dr. de Jong reported receiving grants from Astellas Pharma and personal fees from Bayer Pharma, outside the submitted work. Dr. Jewett reported receiving honoraria from Pfizer, Ipsen, Olympus, and Theralase Therapeutics. Dr. van Thienen reported receiving personal fees from Roche and fees to his institution for training (European Society for Medical Oncology 2017) from Novartis, outside the submitted work. Dr. Blank reported receiving personal fees for advisory roles for BMS, MSD, Roche, GlaxoSmithKline, Eli Lilly and Company, Novartis, and Pfizer, and grants from Novartis and BMS, outside the submitted work. Dr. Lattouf reported receiving honoraria from Janssen and Bayer for participation in advisory boards, outside the submitted work. Dr. Powles reported receiving grants from AstraZeneca and Roche, and personal fees from AstraZeneca, Roche, Pfizer, Novartis, Merck & Co, and BMS, outside the submitted work. Dr. Wood reported receiving research funding to her institution from Pfizer, and clinical trial funding to her institution from Novartis, Merck & Co, Roche, AstraZeneca, and BMS, outside the submitted work. No other disclosures were reported.
Funding Information:
Funding/Support and role of the sponsor: This study was supported by Pfizer and Kankerbestrijding/KWF from the Netherlands through the Cancer Research Fund of the European Organisation for Research and Treatment of Cancer . The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2019 European Association of Urology
PY - 2019/10
Y1 - 2019/10
N2 - The European Organisation for Research and Treatment of Cancer SURTIME trial explored timing of sunitinib, a tyrosine kinase inhibitor (TKI), and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Previous retrospective studies suggest increased surgeryrelated adverse events (AEs) after presurgical TKI. We report surgical safety from a randomised comparison of CN before or after sunitinib. In-hospital mortality, 30-d readmission rate, and intraoperative and 30-d postoperative AEs according to Common Terminology Criteria for Adverse Events version 4 and Clavien-Dindo (CD) were analysed. Patients were randomised 1:1 to immediate CN followed by sunitinib versus sunitinib followed by deferred CN 24 h after the last dose of sunitinib. None of the tumours in the deferred arm became unresectable, and only two patients had a sunitinib-related delay of CN of >2 wk. AEs related to surgery (all grades) in the immediate and deferred arms occurred in 52% and 53% after CN, respectively, although the number of intraoperative surgery-related AEs was higher in the immediate arm. Postoperative AEs (CD >= 3), 30-d readmission, and in-hospital mortality rates were 6.5%, 13%, and 4.3% in the immediate arm and 2.5%, 7.5%, and 2.5% in the deferred arm, respectively. There were no differences in surgery time, blood loss, and hospital stay.Patient summary: Patients with metastatic kidney cancer do not have more surgical complications irrespective of whether they are treated with systemic therapy before or after surgery. (C) 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.
AB - The European Organisation for Research and Treatment of Cancer SURTIME trial explored timing of sunitinib, a tyrosine kinase inhibitor (TKI), and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Previous retrospective studies suggest increased surgeryrelated adverse events (AEs) after presurgical TKI. We report surgical safety from a randomised comparison of CN before or after sunitinib. In-hospital mortality, 30-d readmission rate, and intraoperative and 30-d postoperative AEs according to Common Terminology Criteria for Adverse Events version 4 and Clavien-Dindo (CD) were analysed. Patients were randomised 1:1 to immediate CN followed by sunitinib versus sunitinib followed by deferred CN 24 h after the last dose of sunitinib. None of the tumours in the deferred arm became unresectable, and only two patients had a sunitinib-related delay of CN of >2 wk. AEs related to surgery (all grades) in the immediate and deferred arms occurred in 52% and 53% after CN, respectively, although the number of intraoperative surgery-related AEs was higher in the immediate arm. Postoperative AEs (CD >= 3), 30-d readmission, and in-hospital mortality rates were 6.5%, 13%, and 4.3% in the immediate arm and 2.5%, 7.5%, and 2.5% in the deferred arm, respectively. There were no differences in surgery time, blood loss, and hospital stay.Patient summary: Patients with metastatic kidney cancer do not have more surgical complications irrespective of whether they are treated with systemic therapy before or after surgery. (C) 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.
KW - Renal cell carcinoma
KW - Cytoreductive nephrectomy
KW - Surgical safety
KW - RENAL-CELL CARCINOMA
KW - PLANNED NEPHRECTOMY
KW - EFFICACY
KW - THERAPY
U2 - 10.1016/j.eururo.2019.06.006
DO - 10.1016/j.eururo.2019.06.006
M3 - Article
C2 - 31227307
SN - 0302-2838
VL - 76
SP - 437
EP - 440
JO - European Urology
JF - European Urology
IS - 4
ER -